This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
68
Epoetin Hospira Single Dose Vial
Epoetin Hospira Multi-Dose Vial
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Maximum serum concentration (C max) of PF-06946151 SDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Maximum serum concentration (C max) of PF-06946151 MDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Time to reach maximum concentration (T max) of PF-06946151 SDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Time to reach maximum concentration (T max) of PF-06946151 MDV
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Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 SDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 MDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Number of subjects with adverse events (AEs) by severity and relationship to treatment
Time frame: Day 1 through approximately Day 30 after Period 2
Number of subjects with abnormal physical exam findings
Time frame: Day 1 through approximately Day 30 after Period 2
Percentage of subjects with the development of Anti-Drug Antibodies
Time frame: Day 1 through approximately Day 30 after Period 2
Number of subjects with change from baseline in laboratory results
Time frame: Day 1 through approximately Day 30 after Period 2
Number of subjects with clinically relevant changes in vital signs since baseline
Time frame: Day 1 through approximately Day 30 after Period 2
Percentage of subjects with the development of Neutralizing Antibodies
Time frame: Day 1 through approximately Day 30 after Period 2